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NCT04597918 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate Aqueous Humor and Multimodal Imaging Biomarkers in Treatment-Naïve Participants With Diabetic Macular Edema Treated With Faricimab
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 99
- Enrollment target
NCT04597918: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT04597918 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 99 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04597918, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 99 participants
- Enrollment target
Study Summary
This is an exploratory, prospective, multicenter, open-label, single-arm, interventional, Phase IIb study designed to explore the associations over time between clinical assessments, multimodal imaging assessments, aqueous humor (AH) biomarker patterns, and genetic polymorphisms in participants with diabetic macular edema (DME) who are treated with faricimab.
Primary Outcome
The ETDRS DRSS score of each participant's study eye was assessed using ultra-wide field color fundus photography (UWF-CFP) taken by trained personnel at the study sites. Analysis of the fundus photographs was performed by the central reading center, and the percentage of participants with a ≥2-step improvement from baseline was summarized along with a two-sided 95% Clopper-Pearson exact confidence interval. Baseline was defined as the participant's last observation prior to initiation of study
Interventions
- DRUG Faricimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2020-11-25 |
| Est. Completion | 2022-12-22 |
| Phase | Phase 2 |
What the finished NCT04597918 record still lists
NCT04597918 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 1 intervention - of which Faricimab is the first listed.
NCT04597918 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04597918 about?
NCT04597918 is a clinical study titled "A Study to Investigate Aqueous Humor and Multimodal Imaging Biomarkers in Treatment-Naïve Participants With Diabetic Macular Edema Treated With Faricimab". This is an exploratory, prospective, multicenter, open-label, single-arm, interventional, Phase IIb study designed to explore the associations over time between clinical assessments, multimodal imaging assessments, aqueous humor (AH) biomarker patterns, and genetic polymorphisms in participants with...
What is the current status of trial NCT04597918?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 99 participants. The study started on 2020-11-25. Estimated completion is 2022-12-22.
What interventions are being tested in trial NCT04597918?
The interventions under investigation include: Faricimab (DRUG).
Who is sponsoring clinical trial NCT04597918?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04597918's enrollment target sits among peer trials
99 738th of 2000 higher than 1,258 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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